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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
  • The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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Application Number P060033
Current Protocol Accepted 02/01/2008
Study Name Dual Antiplatelet Therapy EDUCATE
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multi-center study designe to further understand Endeavor stent treatment patterns and   show the rest ...
Study Population Description This device is indicated for improving coronary luminal diameter in patients with ischemic heart disease   show the rest ...
Sample Size A minimum of 2,000 patients and a maximum of 4,000 patients, 100-150 sites
Data Collection Endpoints that will be analyzed include: 1) definite and probable stent thrombosis at one year;   show the rest ...
Followup Visits and Length of Followup Patients will be followed at 3 , 6, 9, 12, 15, 18, 24, 30, and   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 2262 patients were enrolled and followed from baseline. Of those enrolled, 1,440 patients were considered   show the rest ...
Actual Number of Sites Enrolled A total of 92 sites were included in this study.
Patient Followup Rate At 12 months, the follow-up rate was 87.9%. For the non-randomized group at 24 months,   show the rest ...
Final Safety Findings At one year, the Academic Research Consortium (ARC)-defined definite/probable stent thrombosis rate

was 1.3%. The combined   show the rest ...
Final Effectiveness Findings Rates of DAPT usage and compliance were as expected and per protocol, indicating use of   show the rest ...
Study Strengths and Weaknesses The study observed clinical outcomes in a broad unselected patient population during one year, and   show the rest ...
Recommendations for Labeling Changes A labeling update is not needed because Medtronic Vascular has ceased manufacturing and distribution of   show the rest ...

Dual Antiplatelet Therapy EDUCATE Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
6 month report 08/01/2008 08/04/2008 Overdue/Received
12 month report 01/26/2009 01/26/2009 On Time
18 month report 07/26/2009 07/23/2009 On Time
2 year report 01/14/2010 01/14/2010 On Time
3 year report 01/31/2011 01/31/2011 On Time
4 year report 01/31/2012 01/30/2012 On Time
5 year report 01/30/2013 01/30/2013 On Time
6 year report 01/30/2014 01/30/2014 On Time
final report 12/31/2014 12/19/2014 On Time
revised final report 11/20/2015 11/20/2015 On Time

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